BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4092667 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17082
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    February 24, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# N(B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. DEVICE INTERROGATION REVEALED AT THE TIME OF RETURN THE PUMP DELIVERED MORPHINE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS EXPLANTED DUE TO SKIN IRRITATION AND THINNING. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE CATHETER WAS ALSO EXPLANTED. THE REASON FOR CATHETER REMOVAL WAS NOTED AS ¿OTHER.¿ FOLLOW UP HAS BEEN REQUESTED REGARDING THE REASON FOR CATHETER REMOVAL, THE PATIENT STATUS PRIOR TO THE EVENT, AND THE DRUGS CONTAINED IN THE PUMP HAS BEEN REQUESTED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571587 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention